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Comparing the Accuracy of Different Blood Glucose Monitoring Systems (CGM and FGM)

N

Nanjing Medical University

Status

Unknown

Conditions

Type 2 Diabetes

Treatments

Device: FGM
Device: CGM

Study type

Interventional

Funder types

Other

Identifiers

NCT04099745
KY20190823-02

Details and patient eligibility

About

To compare the accuracy of different blood glucose monitoring systems (CGM and FGM) in diabetic patients with insufficient islet function.

Full description

To compare the accuracy of different blood glucose monitoring systems (CGM and FGM) in diabetic patients with insufficient islet function with Venous Blood Glucose (including FGM early, middle and late, pre-and post-meal, high and low blood glucose).

Enrollment

30 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • volunteer to participate and be able to sign informed consent prior to the trial.
  • patients with type 2 diabetes or type 1 diabetes, aged 18-80 years old.
  • No acute complications such as diabetic ketoacidosis, diabetic hyperosmolar syndrome, etc.
  • Subjects are able and willing to monitor peripheral blood sugar and regularity of diet and exercise.

Exclusion criteria

  • Patients with insulin allergy.
  • Impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value; Serum creatinine was 1.3 times higher than the upper limit of normal.
  • Drug abuse and alcohol dependence in the past 5 years.
  • Systemic hormone therapy was used in the last three months.
  • Patients with poor compliance and irregular diet and exercise.
  • Patients with pregnancy, lactation or pregnancy intention.
  • Any other obvious conditions or associated diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors and other diseases, other pancreatic diseases, history of mental diseases.

Trial design

Primary purpose

Health Services Research

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

CGM(continuous glucose monitoring)
Experimental group
Description:
Each diabetic patient received three CGM tests within 14 days of FGM monitoring, on days 1-3, 6-9 and 12-14, respectively.
Treatment:
Device: CGM
FGM(Flash glucose monitoring)
Experimental group
Description:
Each diabetic patient received one FGM test for 14 days.
Treatment:
Device: FGM

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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